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12/26/2006

Safety Concern Widens for Gadolinium Contrast Agents

Cheryl A. Thompson

FDA on Friday reported that a debilitating, potentially fatal skin disorder previously linked to Omniscan has the potential to occur in patients with moderate to end-stage kidney disease exposed to any gadolinium-containing contrast agent.

Nephrogenic systemic fibrosis or nephrogenic fibrosing dermopathy has developed in at least 90 patients with moderate to end-stage kidney disease after they had a magnetic resonance imaging or magnetic resonance angiography scan with a gadolinium-containing contrast agent, according to the "Public Health Advisory" issued by FDA.

Whenever possible, the agency said, clinicians must not expose patients with moderate to end-stage kidney disease to a gadolinium-containing contrast agent. If exposure is necessary, prompt dialysis after the imaging procedure should be considered.

FDA had initially announced in June that the skin disorder had been reported in 25 patients with kidney failure who received GE Healthcare's Omniscan as part of magnetic resonance angiography in Europe. The 25 patients in Denmark and Austria had reportedly received higher doses of the contrast agent than are listed in the labeling for the U.S.-distributed product. In addition, the FDA-approved labeling for the product does not discuss its use in magnetic resonance angiography.

In the nearly seven months since that announcement, FDA said it had received reports of the skin disorder developing after patients' exposure to gadolinium-containing contrast agents other than Omniscan. Also, some of the patients had received the contrast agent as part of magnetic resonance imaging. Some had even received the agent in doses not considered "high" by FDA standards.

Five gadolinium-containing contrast agents are approved for marketing in the United States: gadobenate dimeglumine, or MultiHance, by Bracco Diagnostic Inc.; gadodiamide, or Omniscan; gadopentetate dimeglumine, or Magnevist, by Berlex; gadoteridol, or ProHance, by Bracco; and gadoversetamide, or OptiMark, by Mallinckrodt Inc.

Nephrogenic systemic fibrosis or nephrogenic fibrosing dermopathy, FDA said, is characterized by areas of tight, rigid skin. Patients may experience burning, itching, swelling, and hardening of the skin. Red or dark patches may appear on the skin, and yellow spots may appear on the whites of the eyes. Stiffness in the joints may develop, making it difficult for patients to move or straighten their arms, hands, legs, or feet. Patients may feel pain deep in the hip bones or ribs and have muscle weakness in general.